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Background: Posterior cervical foraminotomy (posterior surgery) is a valid alternative to anterior discectomy with fusion (anterior surgery) as a surgical treatment of cervical radiculopathy, but the quality of evidence has been limited. The purpose of this study was to compare the clinical outcome of these treatments after 2 years of follow-up. We hypothesized that posterior surgery would be noninferior to anterior surgery. Methods: This multicenter, randomized, noninferiority trial assessed patients with single-level cervical radiculopathy in 9 Dutch hospitals with a follow-up duration of 2 years. The primary outcomes measured reduction of cervical radicular pain and were the success ratio based on the Odom criteria, and arm pain and decrease in arm pain, evaluated with the visual analog scale, with a 10% noninferiority margin, which represents the maximum acceptable difference between the new treatment (posterior surgery) and the standard treatment (anterior surgery), beyond which the new treatment would be considered clinically unacceptable. The secondary outcomes were neck pain, Neck Disability Index, Work Ability Index, quality of life, complications (including reoperations), and treatment satisfaction. Generalized linear mixed effects modeling was used for analyses. The study was registered at the Overview of Medical Research in the Netherlands (OMON), formerly the Netherlands Trial Register (NTR5536). Results: From January 2016 to May 2020, 265 patients were randomized (132 to the posterior surgery group and 133 to the anterior surgery group). Among these, 25 did not have the allocated intervention; 11 of these 25 patients had symptom improvement, and the rest of the patients did not have the intervention due to various reasons. At the 2-year follow-up, of 243 patients, primary outcome data were available for 236 patients (97%). Predicted proportions of a successful outcome were 0.81 after posterior surgery and 0.74 after anterior surgery (difference in rate, 20.06 [1-sided 95% confidence interval (CI), 20.02]), indicating the noninferiority of posterior surgery. The between-group difference in arm pain was 22.7 (1-sided 95% CI, 7.4) and the between-group difference in the decrease in arm pain was 1.5 (1-sided 95% CI, 8.2), both confirming the noninferiority of posterior surgery. The secondary outcomes demonstrated small between-group differences. Serious surgery-related adverse events occurred in 9 patients (8%) who underwent posterior surgery, including 9 reoperations, and 11 patients (9%) who underwent anterior surgery, including 7 reoperations (difference in reoperation rate, 20.02 [2-sided 95% CI, 20.09 to 0.05]). Conclusions: This trial demonstrated that, after a 2-year follow-up, posterior surgery was noninferior to anterior surgery with regard to the success rate and arm pain reduction in patients with cervical radiculopathy. Level of Evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence. [ABSTRACT FROM AUTHOR]

Accurate pedicle screw placement is a challenge with reported misplacement rates of 10% and higher. A handheld navigation device (HND) may provide accuracy equal to CT-based navigation (CT-Nav) but without the cost and complexity. To study the accuracy of a handheld navigation device for pedicle screw placement. This prospective cross-sectional study with consistently applied reference standard enrolled 20 patients undergoing 92 pedicle screw placements. Patients who underwent pedicle screw placement between May 2022 and September 2022. Pedicle screw placement accuracy per Gertzbein–Robbins. Once the screw pilot hole was established, the proposed trajectory of the HND was compared with that proposed by CT-Nav. Postoperatively, screw accuracy was graded according to Gertzbein–Robbins by a blinded radiologist based on CT scans. Accuracy was compared between the two systems and published control for fluoroscopy assisted and CT-Nav placement using Bayesian posterior distribution. The trajectory proposed by the HND and CT-Nav were in agreement in 98.9% (95% Exact CI; 94.09%–99.97%). The HND accuracy was 98.9% with 91 screws rated "A" and 1 rated "C". Noninferiority to fluoroscopic placement was achieved because the one-sided normal-approximation 95% CI Lower Bound (LB) of 95.3% is greater than the Performance Goal (PG) of 83.4%. Posthoc analysis demonstrated that the probability of superiority of the HND relative to the historical accuracy rate of 91.5% for fluoroscopy assisted procedures is >0.999 and that the HND's accuracy rate is within 4.5% of CT-Nav of 95.5% is >0.999. No adverse events or intra-operative complications associated with HND were observed. There was 1 (1.1%) intra-operative repositioning and no reoperations for any reason. The accuracy rate of the HND was 98.9%, and the proposed trajectory matched with CT-Nav in 98.9% of the time. This is superior to the historical published accuracy rate for fluoroscopy-assisted procedures and equivalent to the historical published accuracy rate for CT-Nav. Dutch trial register NL74268.058.20. [ABSTRACT FROM AUTHOR]

Background The optimal treatment for odontoid fractures in older people remains debated. Odontoid fractures are increasingly relevant to clinical practice due to ageing of the population. Methods An international prospective comparative study was conducted in fifteen European centres, involving patients aged ≥55 years with type II/III odontoid fractures. The surgeon and patient jointly decided on the applied treatment. Surgical and conservative treatments were compared. Primary outcomes were Neck Disability Index (NDI) improvement, fracture union and stability at 52 weeks. Secondary outcomes were Visual Analogue Scale neck pain, Likert patient-perceived recovery and EuroQol-5D-3L at 52 weeks. Subgroup analyses considered age, type II and displaced fractures. Multivariable regression analyses adjusted for age, gender and fracture characteristics. Results The study included 276 patients, of which 144 (52%) were treated surgically and 132 (48%) conservatively (mean (SD) age 77.3 (9.1) vs. 76.6 (9.7), P  = 0.56). NDI improvement was largely similar between surgical and conservative treatments (mean (SE) −11 (2.4) vs. −14 (1.8), P  = 0.08), as were union (86% vs. 78%, aOR 2.3, 95% CI 0.97–5.7) and stability (99% vs. 98%, aOR NA). NDI improvement did not differ between patients with union and persistent non-union (mean (SE) −13 (2.0) vs. −12 (2.8), P  = 0.78). There was no difference for any of the secondary outcomes or subgroups. Conclusions Clinical outcome and fracture healing at 52 weeks were similar between treatments. Clinical outcome and fracture union were not associated. Treatments should prioritize favourable clinical over radiological outcomes. [ABSTRACT FROM AUTHOR]